Course Overview
To place your pharmaceutical, biotech of advanced therapy on the US market you must first gain FDA regulatory approval. Like all regulatory agencies, the FDA process requires skill and knowledge to navigate efficiently and to ensure fast approval.
This FDA regulatory training course examines the processes, terminology and best practices to ensure your interactions with the FDA are positive. Once completed, you will have the confidence to successfully submit Investigational New Drug Applications (IND) and New Drug Applications (NDA). You will learn the practical regulatory skills to get your pharmaceutical or biotech approved by FDA reviewers. You will also learn how best to gain approval for generics and biosimilars.
University of Nebraska Medical Center –
n/a
IASIS PHARMACEUTICALS HELLAS –
n/a
Individual Booking (verified owner) –
n/a
RaoufAzizi –
I want to travel can you give me a visa
Fresenius Kabi. –
A very informative, experienced presenter
Ipsen –
Detailed and pragmatic journey through FDA-driven processes, stakeholders and meetings.
Blue Pharma –
Great course to understand US FDA specific interactions with the Applicant/MAH from development to life cycle management.
Pfizer –
An interesting overview of FDA regulatory process, it was a small group which allowed for asking many questions
Individual Booking (verified owner) –
Very well organized. I found it very engaging and the speaker was very confident and knowledgeable.
Cheikh sedatt –
شكرا على القبول معكم